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510(k) K040913

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) by Bausch & Lomb — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2004
Date Received
April 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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